Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Anterior Cruciate Ligament Reconstruction With or Without Concomitant AnteroLateral Ligament Reconstruction.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ACL Injury
- Sponsor
- Centre of Postgraduate Medical Education
- Enrollment
- 762
- Locations
- 1
- Primary Endpoint
- Knee stability
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.
Detailed Description
This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded. Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.
Investigators
Rafał Kamiński
Professor CMKP
Centre of Postgraduate Medical Education
Eligibility Criteria
Inclusion Criteria
- •primary ACL injury
Exclusion Criteria
- •no informed consent to participate in the study
- •age under 18 years or above 65
- •multilligament injury or single plane knee instability (medial, lateral)
- •another musculoskeletal disorders in lower limb
- •lower limb deformity requiring axis correction below 4o or above 12.5o
- •joints inflammatory diseases
- •ASA score \> II
Outcomes
Primary Outcomes
Knee stability
Time Frame: 24 months
KT-1000 assesment for knee stability
Secondary Outcomes
- IKDC (International Knee Documentation Committee) subjective knee evaluation(24 months)
- Functional tests(12 months)
- VAS (Visual analog scale)(24 months)
- KOOS (Knee injury and Osteoarthritis Outcome Score)(24 months)
- Tegner Lysholm Knee Scoring Scale(24 months)
- SF-36 (36-Item Short Form Survey)(24 months)
- KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)(24 months)